Pulmonary Emphysema
Conditions
Keywords
PLVR, ELVR, AeriSeal System, foam sealant, emphysematous lung sealant, ELS, COPD, emphysema, polymeric lung volume reduction, heterogeneous, Respiratory Tract Diseases, Lung Diseases, Chronic Obstructive Pulmonary Disease
Brief summary
The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.
Interventions
Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
OTHEROptimal Medical Therapy
Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Sponsors
Aeris Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide informed consent 2. Age ≥ 40 years 3. On optimal medical therapy\* for more than 1 month 4. Advanced upper lobe predominant emphysema confirmed by CT scan 5. Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in each lung based upon CT scan (total 4 available subsegments) 6. MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4) 7. 6MWT distance ≥ 150 m post pulmonary rehab 8. Spirometry 15 minutes after administration of a bronchodilator showing BOTH: 1. FEV1 \< 50% predicted 2. FEV1/FVC ratio \< 70% 9. Plethysmographic lung volumes showing BOTH: 1. TLC \> 100% predicted 2. RV \> 150% predicted 10. DLco ≥ 20% and ≤ 60% predicted 11. Blood gases and oxygen saturation showing BOTH: 1. SpO2 ≥ 90% on ≤ 4 L/min supplemental O2 2. PaCO2 \< 65 torr 12. Smoking history of ≥ 20 pack-years with abstinence for 16 weeks
Exclusion criteria
1. Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation 2. Requirement for ventilator support (other than CPAP or BPAP for sleep apnea) 3. Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks 4. Use of systemic steroids \> 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants or investigational medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in 1 second (FEV1) | 12 Months | Change from baseline measurement of FEV1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes | 12 Months | Change in Patient reported outcome from baseline. |
| Exercise Capacity | 12 months | The change from baseline in Exercise Capacity |
| Radiological Changes | 12 months | The radiological changes from baseline. |
Countries
France, Greece, Israel, Italy, Netherlands, Spain, United States
Outcome results
None listed